Latest posts
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FDA Approves Utebzi for Certain Complicated Urinary Tract Infections
What Was Approved? On June 17, 2026, the U.S. Food and Drug Administration approved Utebzi (tebipenem pivoxil) for adults with complicated urinary tract infections, including pyelonephritis, caused by certain susceptible bacteria. The approval is specifically for adults who have limited or no alternative oral treatment options. What Is Utebzi? Utebzi is an oral penem antibacterial…
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FDA Approves Baxfendy for Adults With Uncontrolled Hypertension
What Was Approved? On May 15, 2026, the U.S. Food and Drug Administration approved Baxfendy (baxdrostat) for the treatment of hypertension in adults whose blood pressure is not adequately controlled with other medications. Baxfendy is used in combination with other antihypertensive drugs. How Does Baxfendy Work? Baxfendy is an aldosterone synthase inhibitor. Aldosterone is a…
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FDA Approves Lumvoa for Thyroid Eye Disease
What Was Approved? On June 26, 2026, the U.S. Food and Drug Administration approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease, or TED. The FDA-approved indication applies regardless of the activity or duration of the disease. FDA also lists Lumvoa among its 2026 novel drug approvals. What Is Thyroid Eye Disease? Thyroid eye…
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FDA Approves Tudriqev With Nivolumab for Certain Adults With Advanced Melanoma
What Was Approved? On August 6, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for certain adults with advanced melanoma. The approval applies to adults with: Tudriqev is not approved as a general treatment for every patient with melanoma. What Is Tudriqev? Tudriqev is a…
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FDA Approves Revtorpyk for Certain HR-Positive, HER2-Negative Advanced Breast Cancers
What Was Approved? On July 14, 2026, the U.S. Food and Drug Administration approved Revtorpyk (gedatolisib) in combination with fulvestrant, with or without palbociclib, for certain adults with advanced breast cancer. The approval applies to adults with: The specific eligibility requirements are important because Revtorpyk is not approved for every patient with HR-positive or HER2-negative…
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FDA Approves Lipfendra, the First Oral PCSK9 Inhibitor for Lowering LDL Cholesterol
What Was Approved? The U.S. Food and Drug Administration approved Lipfendra (enlicitide) as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol, or LDL-C, in adults with hypercholesterolemia, including adults with heterozygous familial hypercholesterolemia (HeFH). Lipfendra is notable because it is the first oral medication approved to inhibit PCSK9. Previous PCSK9 inhibitors have…
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FDA Approves Jideytro for Previously Treated ROS1-Positive Non-Small Cell Lung Cancer
What Was Approved? On July 22, 2026, the U.S. Food and Drug Administration approved Jideytro (zidesamtinib) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, or NSCLC, who have previously received at least one ROS1 kinase inhibitor. Jideytro is an oral targeted cancer therapy designed for tumors driven by abnormal ROS1 signaling.…
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FDA Approves Mimrylo for Adults With Polycythemia Vera
What Was Approved? On August 28, 2026, the U.S. Food and Drug Administration approved Mimrylo (rusfertide) for adults with polycythemia vera, a rare blood disorder in which the body produces too many red blood cells. The approval provides a new treatment option for patients whose disease has not been adequately controlled with existing therapy. What…
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FDA Approves Lytenava for Wet Age-Related Macular Degeneration
What Was Approved? On July 24, 2026, the U.S. Food and Drug Administration approved Lytenava (bevacizumab-vikg) for the treatment of patients with neovascular, or wet, age-related macular degeneration (nAMD). Lytenava is administered directly into the eye by a healthcare professional. What Is Wet Age-Related Macular Degeneration? Wet age-related macular degeneration is a condition that affects…
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FDA Approves Simtriyo for ADHD in Adults and Children Age 6 and Older
What Was Approved? On July 24, 2026, the U.S. Food and Drug Administration approved Simtriyo (centanafadine) extended-release capsules for the treatment of attention-deficit/hyperactivity disorder, or ADHD. Simtriyo is approved for: The FDA labeling does not recommend its use in children younger than 6 years or in children weighing less than 20 kg. What Is Simtriyo?…